Pranoprofen eyedrops containing organic amine

Abstract

An ophthalmic solution containing 0.01 to 0.5 weight % of pranoprofen and 0.1 to 5.0 weight % of an organic amine, such as tromethamine or 4-(2-hydroxyethyl)-1-(2-sulfoethyl)piperazine. Such solution has a desirable stability and does not cause undue irritation when administered to eyes to treat an inflammatory disease such as keratoconjunctivitis.

What is claimed is:  
     
       1. An ophthalmic solution comprising an effective ophthalmic amount of pranoprofen as an active ingredient, an amount of benzalkonium chloride effective as a preservative, and an amount of tromethamine effective to keep the solution stable and clear and lowers eye irritation, said tromethamine being in a concentration of 1 to 2.5% by weight. 
     
     
       2. The ophthalmic solution according to claim  1 , wherein the pranoprofen is in a concentration of 0.01 to 0.5% by weight of. 
     
     
       3. The ophthalmic solution according to claim  1 , wherein the tromethamine is in a concentration of 2.5% by weight. 
     
     
       4. The ophthalmic solution according to claim  1 , wherein the tromethamine is in a concentration 2.0% by weight. 
     
     
       5. The ophthalmic solution according to claim  1 , wherein the pranoprofen is in a concentration of 1.0% by weight. 
     
     
       6. The ophthalmic solution according to claim  1 , wherein the benzalkonium chloride is in a concentration of 0.002 to 0.01% by weight. 
     
     
       7. The ophthalmic solution according to claim  1 , wherein the benzalkonium chloride is in a concentration of 0.005% by weight. 
     
     
       8. The ophthalmic solution according to claim  1 , which has a pH of 6.5 to 8.5. 
     
     
       9. The ophthalmic solution according to claim  1 , which has a pH of 7.6 to 8.0. 
     
     
       10. A stable and clear ophthalmic solution for decreasing eye irritation comprising 0.01 to 0.5% by weight of pranoprofen, 1 to 2.5% by weight of tromethamine and 0.002 to 0.01% by weight of benzalkonium chloride, and having a pH of 6.5 to 8.5. 
     
     
       11. A stable and clear ophthalmic solution for decreasing eye irritation comprising 0.1% by weight of pranoprofen, 1 to 2.5% by weight of tromethamine and 0.005% by weight of benzalkonium chloride, and having a pH of 7.6 to 8.0. 
     
     
       12. The ophthalmic solution according to claim  1 , which further comprises (i) an isotonic agent selected from the group consisting of sodium chloride and glycerin; (ii) a surfactant selected from the group consisting of polyoxyethylene sorbitan monooleate, stearic polyoxyl 40 and polyoxyethylene hydrogenated castor oil; and (iii) a stabilizing agent selected from the group consisting of sodium edetate and sodium citrate. 
     
     
       13. The ophthalmic solution according to claim  1 , wherein the pranoprofen is in a concentration of 0.01 to 0.5% by weight and the benzalkonium chloride is in a concentration of 0.002 to 0.01% by weight. 
     
     
       14. The ophthalmic solution according to claim  1 , wherein the tromethamine is in a concentration of 1% by weight. 
     
     
       15. The ophthalmic solution according to claim  1 , wherein the tromethamine is in a concentration of 2% by weight. 
     
     
       16. The ophthalmic solution according to claim  10 , wherein the tromethamine is in a concentration of 1 by weight. 
     
     
       17. The ophthalmic solution according to claim  10 , wherein the tromethamine is in a concentration of 2.5% by weight. 
     
     
       18. The ophthalmic solution according to claim  11 , wherein the tromethamine is in a concentration of 1 by weight. 
     
     
       19. The ophthalmic solution according to claim  11 , wherein the tromethamine is in a concentration of 2.5% by weight.